Randomised controlled trialindependent cross-checkabstract only checked★ key study I-GRN-01 in-depth review

Is it gluten or another wheat component?

Fructan, Rather Than Gluten, Induces Symptoms in Patients With Self-Reported Non-Celiac Gluten Sensitivity.

Overview

Skodje GI et al.. Gastroenterology 2018 · PMID 29102613 · DOI 10.1053/j.gastro.2017.10.040

In people who think they react to gluten, a wheat sugar (fructan) caused more symptoms than gluten.

Does the study support the specific claim? Partly · Methodological quality: high

Original publication

Plain-language summary

Study explained simply
What did the researchers want to find out?

Gluten vs fructan

How was the study done?

Blinded crossover RCT

How many people, animals or samples were studied?

59

What was actually found?

Fructan, not gluten

How large was the observed effect?

GSRS 38.6 vs 33.1

What do the results mean in everyday life?

Symptoms may come from wheat carbohydrates

What are the study's limitations?

Small

What does it say about Elawady's specific claim?

Partly supports 'not gluten'; says nothing about coeliac disease

Do the results apply to Germany and Europe?

High

What can explicitly not be concluded from this study?

Coeliac disease

Scientific in-depth review

1. Full reference

Authors
Skodje GI et al.
Journal
Gastroenterology
Year
2018
Identifier
PMID 29102613 DOI 10.1053/j.gastro.2017.10.040
Verification
verified – PubMed efetch 2026-10-25
Retracted
no
Corrections
none
Extent checked
abstract only
Conflicts of interest and funding

None stated.

2. Research question

Do gluten or fructans cause symptoms in self-reported NCGS?

3. Study design and population

Study design
Randomised controlled trial – Randomised double-blind placebo-controlled crossover trial
Population

59 adults on self-instituted gluten-free diet, coeliac excluded

Country

Norway

Period

Oct 2014-May 2016

Sample size

59

Inclusion and exclusion criteria

Coeliac disease excluded

4. Methods and endpoints

Exposure / intervention

Gluten 5.7 g/day or fructans 2.1 g/day in muesli bars, 7 days each

Comparator

Placebo

Endpoints

GSRS-IBS score

Statistical methods

Linear mixed model

5. Actual results

Results

GSRS-IBS: gluten 33.1, fructan 38.6, placebo 34.3 (P=0.04); bloating 9.3, 11.6, 10.1 (P=0.004); fructan > gluten (P=0.049). No difference gluten vs placebo.

Absolute risks

not applicable

Authors' conclusion

Fructans, not gluten, induced symptoms in self-reported NCGS.

6. Strengths

  • Blinded crossover

7. Weaknesses

  • Small; short challenges

8. Risk of bias

Orienting tool
RoB 2
Type of assessment
simplified assessment (abstract only)
Full formal assessment
no
Overall risk of bias
low
Rationale

Simplified judgement.

9. Assessment of the statistical interpretation

Small absolute differences.

10. Relevance to the specific claim

Partly supports C-GRN-01 (gluten not the trigger in self-reported NCGS).

11. Independent contrary findings

12. Transferability to Germany and Europe

High (Norway).

13. Overall methodological judgement

Good trial; shows symptoms from wheat may be due to fructans.

Multidimensional assessment
Multidimensional assessment
Authenticity of the sourceverified
Methodological qualityhigh
Risk of biaslow
Precision of resultsmoderate
Directnessdirect
Reproducibilitypartly replicated
Consistency with the overall evidencemixed
Regional transferabilityhigh
Adequacy of the interpretation (by the archive)not applicable

14. Open questions

15. Linked fact checks